Clinical studies

Discover our clinical studies and their summaries to confirm the effectiveness of RestoreX™.

Study No. 1A | Study No. 2A | Study No. 3A | Study No. 4A | Study No. 5A |

Clinical evaluation of penile traction therapy with RestoreX™ in men with Peyronie's disease: Results of the open phase and follow-up phase.

Jason Joseph, Matthew J Ziegelmann, Manaf Alom, Joshua Savage, Tobias S Köhler, Landon Trost

Summary of the study

CONTEXT

A randomized, controlled clinical study evaluating the efficacy of therapy
Penile traction with RestoreX™ in men with Peyronie's disease (PD) has been completed and 3-month results have been previously reported.

This study presents
the results of the open access and follow-up phases of the initial trial.

METHOD

A randomized, controlled clinical study was conducted from 2017 to 2019 on 110 men with Peyronie's disease.

Men were randomized in a 3:1 ratio to the RestoreX™ (PTT) group and the no-treatment (control) group for 3 months, followed by open-access and 3-month follow-up phases.

Primary endpoints included adverse events (AEs), changes in penile curvature and length, erectile function, and standardized and nonstandardized assessments of Peyronie's disease.

RESULTS

Primary endpoints include safety, penile length, penile curvature, Peyronie's disease questionnaire, International Index of Erectile Function, and satisfaction.

At 6 months (n = 64) and 9 months (n = 63), results were reported, with a mean duration of penile traction therapy (PTT) use of 31.1 minutes.

No significant adverse events were reported, with temporary redness and discomfort being the most common symptoms and resolving within minutes.

In the intention-to-treat analysis, men in the control to PTT groups experienced significant improvements in length (1.7-2.0 cm) and curvature (18-20%).

Men in the PTT group also gained additional length (0.6-0.8 cm) without further improvement in curvature.

An analysis based on PTT use for ≥15 minutes per day showed length gains of 2.0–2.3 cm (the largest to date) and an improvement in curvature of 18–21%.

All domains of sexual function of the International Index of Erectile Function and the Peyronie's Disease Questionnaire were significantly improved (except the orgasmic domain).

95% of men treated for 6 months saw length gains (mean 2.0–2.2 cm), and 61% saw improvements in curvature (16.8–21.4° [32.8–35.8%]).

RestoreX™ was preferred 3-4 times more often than all other Peyronie's disease treatments, and 100% of men preferred it over other PTT devices.

CLINICAL IMPLICATIONS

Daily use of RestoreX™ for 30 minutes results in significant improvements in length and curvature in men with Peyronie's disease, without significant adverse events.

STRENGTHS AND LIMITATIONS

Strengths of this study include the largest randomized study of penile traction therapy (PTT), blinded assessments, and inclusion of all participants with few restrictions.

Limitations include sample size, which precludes comparisons between treatment groups, and the lack of a long-duration treatment arm (>3-9 hours).

CONCLUSION

Penile traction therapy (PTT) with RestoreX™ results in significant improvements in length, curvature, and subjective and objective measures of sexual function without significant adverse events. RestoreX™ PTT represents a safe, conservative, and inexpensive option for the management of men with Peyronie's disease.

Results of a novel penile traction device in men with Peyronie's disease.

Matthew Ziegelmann, Josh Savage, Amir Toussi, Manaf Alom, David Yang, Tobias Kohler and Landon Trost.

Summary of the study

OBJECTIVE

Current penile traction therapy devices have significant limitations, including the need to use them for 3 to 8 hours per day.

In response to these issues, the new RestoreX™ penile traction therapy device was developed in collaboration with the Mayo Clinic.

MATERIALS AND METHODS

We conducted a randomized, controlled, single-blind, intention-to-treat study (ClinicalTrials.gov NCT03389854) in men with Peyronie's disease who were assigned to use the penile traction therapy device for 30 to 90 minutes per day, or no therapy for 3 months.

Study inclusion criteria were a curve of 30 degrees or greater, with no study exclusion due to complex curves, hourglass deformity, previous treatments or surgeries for Peyronie's disease, or calcifications.

The primary endpoint was safety, and secondary endpoints were penile length and curvature, and responses to questionnaires.

RESULTS

A total of 110 men were randomly assigned in a ratio of 3 to the penile traction therapy group or the control group.

The cohorts were well matched, with a mean age of 58.4 years, a history of Peyronie's disease of 49.7 months, and a mean curvature of 59.3 degrees.

Overall, penile traction therapy was well tolerated, with only transient and mild adverse events reported.

At 3 months, men undergoing penile traction therapy showed significant improvements compared with the control group in penile length (1.5 vs. 0 cm, p < 0.001), curvature (11.7 vs. 1.3 degrees, p < 0.01), and erectile function (4.3 vs. -0.7, p < 0.01) according to the International Index of Erectile Function among Men with Erectile Dysfunction.

Overall, 77% of men undergoing penile traction therapy experienced an improvement in curvature (average of -17.2 degrees in 28.2% of respondents), while 94% experienced a gain in length (1.6 cm in 10.9%).

Reverse flexion and the white line indicator improved the efficiency, validating the main innovations of the device.

Among men who had previously used other penile traction therapy devices, 100% preferred the RestoreX™ device.

CONCLUSION

Penile traction therapy with the RestoreX™ device for 30 to 90 minutes daily has been shown to be safe and to result in significant and clinically meaningful improvements in penile curvature and length in men with Peyronie's disease, and in erectile function in men with erectile dysfunction and Peyronie's disease, without any significant adverse events.

To our knowledge, these data represent the only improvements reported for a device used less than 3 to 8 hours per day.

Comparative cost-effectiveness of surgery, collagenase Clostridium histolyticum, and penile traction therapy in men with Peyronie's disease in an era of effective clinical treatment.

Kevin Wymer, MD, Tobias Kohler, MD, and Landon Trost, MD

Summary of the study

CONTEXT

Traditionally, surgery has been considered the gold standard treatment for Peyronie's disease (PD).

Less invasive alternatives, such as collagenase Clostridium histolyticum (CCH) and traction therapy, have been proposed and proven effective.

OBJECTIVE

To compare the cost-effectiveness of management options for Peyronie's disease (PD).

METHODS

A Markov analytical model was created to compare the cost-effectiveness of treatment with a novel traction device, RestoreX™ (RXPTT), versus CCH and surgery.

Results were obtained from prospective data from a single institution, including 63 men treated with RXPTT, 115 with CCH, and 23 with a fold or incision and graft.

Costs were based on 2017 Medicare reimbursements and utility values ​​from the literature.

KEY OUTCOME MEASURES

Model results included complications for each treatment option, as well as the probability of success, defined as a 20% improvement in curvature.

Univariate and multivariate sensitivity analyses were performed to test the robustness of the model.

RESULTS

The overall success rates were 96% (surgery), 66% (CCH), and 48% (RXPTT).

After 10 years of treatment, RXPTT was the most cost-effective, with mean costs per patient of $883 (RXPTT), $11,419 (surgery), and $33,628 (CCH).

Both CCH and surgery resulted in a gain in quality-adjusted life years (QALYs) compared with RXPTT (9.44 and 9.36 vs. 9.27, respectively).

Sensitivity analysis showed greater cost-effectiveness for surgery with lower rates (less than 46%) of postoperative erectile dysfunction or length loss (less than 3%).

CCH became more cost-effective at lower costs ($16,726) or higher success rates (greater than 76%).

Multivariable sensitivity analysis, with a willingness-to-pay threshold of $100,000 per QALY, showed that the most cost-effective strategy was RXPTT in 49% of simulations, surgery in 48%, and CCH in 3%.

At a willingness-to-treat threshold of $150,000 per QALY, the most cost-effective treatment option was RXPTT in 33% of simulations, surgery in 55%, and CCH in 12%.

CLINICAL IMPLICATIONS

In an era of value-based care, this model can guide the selection of cost-effective treatments based on provider, patient, and payer characteristics.

STRENGTHS AND LIMITATIONS

The current study represents the first comparison of the cost-effectiveness of treatment modalities for Peyronie's disease, strengthened by prospective data collection, large CCH and traction samples, and robust sensitivity analyses.

Consistent with economic models, the model is limited by assumptions and may not apply to all situations.

CONCLUSION

RXPTT represents a more cost-effective method of achieving a 20% improvement in curvature compared to surgery or CCH.

Depending on treatment goals, surgical complication rate, and willingness-to-pay threshold, surgery and CCH may become more cost-effective in specific scenarios.

Clinical experience of penile traction therapy in men undergoing collagenase Clostridium histolyticum treatment for Peyronie's disease.

Matthew J. Ziegelmann, Boyd R. Viers, Brian D. Montgomery, Ross A. Avant, Joshua B. Savage, and Landon W. Trost

Summary of the study

OBJECTIVE

To evaluate outcomes in men undergoing collagenase clostridium histolyticum (CCH) therapy combined with concurrent penile traction therapy (PTT) for the treatment of Peyronie's disease (PD).

METHOD

We identified patients treated with CCH between March 2014 and July 2016.

Patients were encouraged to perform manipulations and PTT between injection series.

A final curvature assessment was performed after patients completed their CCH treatment.

A prospective database was maintained, including patient-reported frequency and duration of PTT.

Statistical analysis was performed to evaluate the results according to the use and duration of PTT.

RESULTS

A total of 51 patients completed CCH treatment and had complete objective data for analysis.

The mean (standard deviation [SD]) initial curvature was 66.7 (25.0) degrees, and the mean (SD) improvement after CCH was 20.9 (17.3) degrees (P < 0.0001).

Thirty-five (69%) men reported daily PTT for a mean (SD) of 9.8 (6.3) hours per week.

No significant differences were identified in the degree of curvature improvement based on PTT frequency or duration (P = 0.40).

Similarly, no association between PTT and functional outcomes, including restoration of sexual intercourse and prevention of surgery, was identified.

Stretched penile length increased nonsignificantly by a mean (SD) of +0.4 (1.5) cm in the PTT group, compared with -0.35 (1.5) in the non-PTT group (P = 0.21).

CONCLUSION

The current series represents a “true to life” experience, where usage patterns, attrition and compliance issues are relevant factors impacting effectiveness.

PTT use with Andropenis decreased in both frequency and duration with subsequent injection series, and there was no significant difference in improvement in curvature or stretched penile length with an average of 10 hours of concurrent weekly PTT.

UROLOGY 104: 102-109,2017. © 2017 Elsevier Inc

Efficacy of the combination of collagenase Clostridium histolyticum and RestoreX™ penile traction therapy in men with Peyronie's disease.

Manaf Alom, MBBS, Kiran L. Sharma, PhD, Amir Toussi, MD, Tobias Kohler, MD, and Landon Trost, MD

Summary of the study

CONTEXT

Previous studies on penile traction therapy (PTT) devices
have shown limited or no efficacy when combined with intralesional treatments for Peyronie's disease (PD).

Recently, data from randomized trials have demonstrated the effectiveness of a new PTT device, RestoreX™, developed in collaboration with the Mayo Clinic, in men with PD.

OBJECTIVE

To evaluate the safety and efficacy of treatment with the RestoreX™ device in combination with collagenase clostridium histolyticum (CCH) compared with CCH alone and CCH with other penile traction therapy (PTT) devices.

METHOD

A prospective registry was maintained for all men undergoing CCH injections for Peyronie's disease between March 2014 and January 2019.

Assessments were performed at baseline, during each series of injections, and after treatment ended.

Those who completed their therapy (8 injections or earlier if they were satisfied) were divided into three groups:

• Group 1 (CCH only)
• Group 2 (CCH plus any PTT device other than RestoreX™)
• Group 3 (CCH plus RestoreX™)
  

RESULT

Of the 287 men for whom data on penile traction therapy (PTT) use were available, 113 had completed treatment with all objective data available, thus comprising the current cohort.

Baseline demographic and pathophysiological variables were similar among the three groups, with the exception of penile length and medications previously used for Peyronie's disease (PD).

After treatment, group 3 showed significantly greater improvements in curvature (mean 20.3/31% for group 1, 19.2/30% for group 2, and 33.8/49% for group 3), length (0.7 cm/-4%, -0.4 cm/-2%, and +1.9 cm/+17%, respectively), and subjectively estimated curvature improvement (44%, 32%, and 63%, respectively), despite shorter daily PTT use (0.9 versus 1.9 hours per day).

Group 3 was more likely than the other groups to achieve 20% and 50% improvements in curvature, a 1 cm gain in length, and a 20% improvement in length.

All results were statistically significant for group 3 compared with groups 1 and 2, but not between groups 1 and 2, even after controlling for baseline characteristics and isolating a subgroup using PTT for 3 hours per day (group 2).

Group 3 was 6.9 times more likely to achieve a 20% improvement in curvature, 3.5 times more likely to achieve a 50% improvement in curvature, and 10.7 times more likely to achieve... (Text is truncated here, but the main idea is that Group 3 performed better than the other groups.)

CLINICAL IMPLICATIONS

Use of the RestoreX™ device improves mean curvature outcomes by 71% and increases penile length in men with Peyronie's disease (PD) receiving collagenase clostridium histolyticum (CCH) therapy.

STRENGTHS AND LIMITATIONS OF THE STUDY

Strengths of the study include a prospective registry, consistent assessments, the largest single-site series with complete post-treatment outcomes reported to date, the largest penile traction therapy (PTT) series reported to date, and a real-world clinical design.

Limitations include the non-randomized methodology and the fact that the study was conducted at a single site.

CONCLUSION

The combination of RestoreX™ and collagenase Clostridium histolyticum (CCH) is associated with significantly greater improvements in curvature and length compared to CCH alone or CCH with other penile traction therapy (PTT) devices.